A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment

NCT05841680 | Completed Results

• 1 other identifier: IRB-23-0040
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Lengthy wait times to access treatment for youth anxiety disorders is a critical issue. To help address this issue, investigators will pursue the following aims in N = 65 families on waitlists for outpatient youth anxiety psychosocial treatment. Aim 1 Pilot Phase: Develop and pilot a single session intervention (SSI) tailored for families on waitlists for outpatient psychosocial treatment for youth anxiety disorders. Investigators will pilot the single session intervention (SSI) with N = 5 families and use cognitive response interviewing to obtain data from parents and children, ensuring the content is understandable and accessible. The SSI will include psychoeducation on the cognitive behavioral conceptualization of anxiety, introduction to self-regulation strategies to manage physiological manifestations of anxiety, and cognitive restructuring of anxiogenic thoughts. The SSI will also involve parents and present strategies on how parents can support their children in managing anxious feelings and thoughts. Investigators will refine the SSI based on these data. Following the Pilot Phase, investigators will enroll an additional N = 60 families and randomize them to either the SSI (n = 30) or waitlist control (n = 30). Aim 2 Test Phase Acceptability, and Satisfaction: Examine acceptability of the refined SSI, as well as satisfaction with the SSI. Investigators hypothesize that users will find the module to be acceptable and will report high satisfaction. Aim 3 Test Phase Anxiety Outcomes: Demonstrate reductions in youth anxiety symptom severity. Investigators hypothesize that anxiety symptom severity and impairment will be significantly lower among youth who receive the refined SSI relative to youth on waitlist control. The main risk or discomfort from this research is that participants might feel uncomfortable answering questions about their behavior and feelings. Another possible risk is breach of confidentiality that could identify a participant as having elevated levels of anxiety. The benefits of this SSI would include increasing accessibility and scalability of treatment for youth anxiety disorders. Overall, this study will provide critically needed data to advance resource efficient treatment options for youth anxiety disorders.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (4)

• Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment

  Posttreatment parent rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.

  1 week after first session

• Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment

  Posttreatment child rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.

  1 week after first session

• Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up

  Follow up parent rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.

  4 weeks after first session

• Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up

  Follow up child rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.

  4 weeks after first session

Secondary Outcomes (18)

• Screen for Child Anxiety Related Emotional Disorders - Child Version at Pre

  first session at baseline

• Screen for Child Anxiety Related Emotional Disorders - Parent Version at Pre

  first session at baseline

• Child Anxiety Impact Scale - Parent Version at Pre

  first session at baseline

• Child Anxiety Impact Scale - Child Version at Pre

  first session at baseline

• Child Anxiety Impact Scale - Parent Version at Posttreatment

  1 week after first session

Study Arms (2)

Waitlist Control

NO INTERVENTION

Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.

Single Session Intervention Receivers

ACTIVE COMPARATOR

Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.

Behavioral: SSI Module

Interventions

SSI Module BEHAVIORAL

Single Session Intervention (SSI) module for youth with anxiety disorders and their parents. The SSI module will include psychoeducation on the cognitive behavioral conceptualization of anxiety, introduction to self-regulation strategies to manage physiological manifestations of anxiety, and cognitive restructuring of anxiogenic thoughts. The SSI module will also involve parents and present strategies on how parents can support their children in managing anxious feelings and thoughts.

Single Session Intervention Receivers

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be between ages 7 and 17 years
• Endorse clinically elevated anxiety symptoms on either parent or youth report, as indicated by a score \> 25 on the Screen for Child Anxiety and Related Emotional Disorders-Child or Parent Versions (SCARED-C/P).

You may not qualify if:

• Parent report of past diagnosis of Autism Spectrum Disorder, Intellectual Disability, Bipolar Disorder, Tourette's Disorder, Psychotic Disorders, or Substance Use Disorders
• Show high likelihood of hurting themselves or others
• Not having access/connectivity needed for telehealth video conferencing to complete the module.

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Coral Gables, Florida, 33156, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Jeremy Pettit
• Organization: Florida International University

jpettit@fiu.edu

3053481671

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: May 3, 2023
• Study Start: February 10, 2023
• Primary Completion: June 9, 2025
• Study Completion: October 1, 2025
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-10

Locations

US (1)